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PH12016501470B1 - Crystalline forms of an androgen receptor modulator - Google Patents

Crystalline forms of an androgen receptor modulator

Info

Publication number
PH12016501470B1
PH12016501470B1 PH12016501470A PH12016501470A PH12016501470B1 PH 12016501470 B1 PH12016501470 B1 PH 12016501470B1 PH 12016501470 A PH12016501470 A PH 12016501470A PH 12016501470 A PH12016501470 A PH 12016501470A PH 12016501470 B1 PH12016501470 B1 PH 12016501470B1
Authority
PH
Philippines
Prior art keywords
androgen receptor
receptor modulator
crystalline forms
modulator
trifluoromethylpyridin
Prior art date
Application number
PH12016501470A
Other versions
PH12016501470A1 (en
Inventor
Nicholas D Smith
Mark R Herbert
Ouathek Ouerfelli
Anna Dilhas
Original Assignee
Aragon Pharmaceuticals Inc
Sloan Kettering Inst Cancer Res
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=49712550&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PH12016501470(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Aragon Pharmaceuticals Inc, Sloan Kettering Inst Cancer Res filed Critical Aragon Pharmaceuticals Inc
Publication of PH12016501470A1 publication Critical patent/PH12016501470A1/en
Publication of PH12016501470B1 publication Critical patent/PH12016501470B1/en

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D401/00Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom
    • C07D401/02Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings
    • C07D401/04Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings directly linked by a ring-member-to-ring-member bond
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/41641,3-Diazoles
    • A61K31/41841,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/08Drugs for disorders of the urinary system of the prostate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P33/00Antiparasitic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/24Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/28Antiandrogens
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07BGENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13Crystalline forms, e.g. polymorphs

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Endocrinology (AREA)
  • Diabetes (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Urology & Nephrology (AREA)
  • Reproductive Health (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
  • Plural Heterocyclic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

Described herein are amorphous and crystalline forms of the androgen receptor modulator 4-[7-(6-cyano-5-trifluoromethylpyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide. Also described are pharmaceutical compositions suitable for administration to a mammal that include the androgen receptor modulator, and methods of using the androgen receptor modulator, alone and in combination with other compounds, for treating diseases or conditions that are associated with androgen receptor activity.
PH12016501470A 2012-06-07 2016-07-26 Crystalline forms of an androgen receptor modulator PH12016501470B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201261656888P 2012-06-07 2012-06-07
PCT/US2013/044116 WO2013184681A1 (en) 2012-06-07 2013-06-04 Crystalline forms of an androgen receptor modulator

Publications (2)

Publication Number Publication Date
PH12016501470A1 PH12016501470A1 (en) 2017-07-10
PH12016501470B1 true PH12016501470B1 (en) 2021-12-10

Family

ID=49712550

Family Applications (2)

Application Number Title Priority Date Filing Date
PH12014502714A PH12014502714B1 (en) 2012-06-07 2014-12-04 Crystalline forms of an androgen receptor modulator
PH12016501470A PH12016501470B1 (en) 2012-06-07 2016-07-26 Crystalline forms of an androgen receptor modulator

Family Applications Before (1)

Application Number Title Priority Date Filing Date
PH12014502714A PH12014502714B1 (en) 2012-06-07 2014-12-04 Crystalline forms of an androgen receptor modulator

Country Status (45)

Country Link
US (9) US9481663B2 (en)
EP (4) EP3348553B1 (en)
JP (3) JP6182209B2 (en)
KR (2) KR102062024B1 (en)
CN (3) CN113135892A (en)
AU (3) AU2013271751B2 (en)
BR (1) BR112014030678A2 (en)
CA (4) CA3114726A1 (en)
CL (1) CL2014003331A1 (en)
CO (1) CO7240407A2 (en)
CR (2) CR20190331A (en)
CY (4) CY1120393T1 (en)
DK (3) DK3348553T3 (en)
EA (3) EA028791B1 (en)
EC (1) ECSP14030098A (en)
ES (3) ES2809738T3 (en)
FR (1) FR21C1050I2 (en)
GT (1) GT201400283A (en)
HK (2) HK1210175A1 (en)
HR (3) HRP20180902T1 (en)
HU (4) HUE038082T2 (en)
IL (5) IL320522A (en)
IN (1) IN2014DN10084A (en)
LT (4) LT3533792T (en)
LU (1) LUC00236I2 (en)
ME (2) ME03815B (en)
MX (1) MX356754B (en)
MY (1) MY187500A (en)
NI (1) NI201400142A (en)
NL (1) NL301144I2 (en)
NO (1) NO2021046I1 (en)
NZ (2) NZ702203A (en)
PE (3) PE20200725A1 (en)
PH (2) PH12014502714B1 (en)
PL (3) PL2858985T3 (en)
PT (3) PT2858985T (en)
RS (3) RS61988B1 (en)
SG (3) SG10201610249TA (en)
SI (3) SI3533792T1 (en)
SM (3) SMT201800311T1 (en)
TR (1) TR201808939T4 (en)
TW (1) TWI532732B (en)
UA (2) UA115665C2 (en)
WO (1) WO2013184681A1 (en)
ZA (1) ZA201500076B (en)

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WO2008119015A2 (en) 2007-03-27 2008-10-02 Sloan-Kettering Institute For Cancer Research Synthesis of thiohydantoins
PE20150099A1 (en) 2011-12-16 2015-01-30 Olema Pharmaceuticals Inc NOVELTY BENZOPYRAN COMPOUNDS, COMPOSITIONS AND USES OF THEM
ES2809738T3 (en) 2012-06-07 2021-03-05 Aragon Pharmaceuticals Inc Crystalline forms of an androgen receptor modulator
WO2014043208A1 (en) 2012-09-11 2014-03-20 Medivation Prostate Therapeutics, Inc. Formulations of enzalutamide
PT3305285T (en) 2012-09-26 2020-11-24 Aragon Pharmaceuticals Inc Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer
JOP20200097A1 (en) 2013-01-15 2017-06-16 Aragon Pharmaceuticals Inc Androgen receptor modulator and uses thereof
CN106795152B (en) * 2014-08-26 2020-01-31 安斯达尔生物技术有限责任公司 protein kinase inhibitor
CR20170217A (en) 2014-12-05 2017-08-30 Aragon Pharmaceuticals Inc ANTI-TARGET COMPOSITIONS
CA2969675C (en) 2014-12-05 2023-06-06 Aragon Pharmaceuticals, Inc. Anticancer compositions
BR112017011788A2 (en) 2014-12-05 2017-12-26 Aragon Pharmaceuticals Inc anticancer compositions
WO2016100905A1 (en) 2014-12-19 2016-06-23 Lutron Electronics Co., Inc. Multi-channel lighting fixture having multiple light-emitting diode drivers
TW201808287A (en) 2016-06-03 2018-03-16 美商艾瑞岡醫藥公司 Anticancer compositions
ES2952770T3 (en) 2016-12-13 2023-11-06 Watson Lab Inc Solid State Forms of Apalutamide
EP4438126A3 (en) 2017-10-16 2025-01-01 Aragon Pharmaceuticals, Inc. Anti-androgens for the treatment of non-metastatic castration-resistant prostate cancer
WO2019135254A1 (en) 2018-01-02 2019-07-11 Mylan Laboratories Limited Apalutamide polymorphs and their preparation thereof
WO2019242439A1 (en) * 2018-06-20 2019-12-26 苏州科睿思制药有限公司 Crystal form of arn-509, preparation method therefor and use thereof
WO2020049598A2 (en) 2018-09-08 2020-03-12 Cipla Limited Apalutamide polymorphs
IT201900003839A1 (en) 2019-03-15 2020-09-15 Olon Spa STABLE AMORPHOUS APALUTAMIDE SYNTHESIS
WO2020234817A1 (en) * 2019-05-21 2020-11-26 Laurus Labs Limited Polymorphic forms of apalutamide and its preparation thereof
IT201900010593A1 (en) 2019-07-01 2021-01-01 Dipharma Francis Srl CRYSTALLINE FORM OF AN ANDROGEN RECEPTOR INHIBITOR
EP4017848A1 (en) * 2019-08-22 2022-06-29 Dr. Reddy's Laboratories Ltd. Process for the preparation of apalutamide
IT201900015974A1 (en) 2019-09-10 2021-03-10 Olon Spa STABLE CRYSTALLINE APALUTAMIDE IN PURE FORM AND PROCESS FOR ITS PREPARATION
CN110590740A (en) * 2019-09-20 2019-12-20 武汉大学 A kind of apalutamide compound and its pharmaceutical preparation
WO2022049265A1 (en) 2020-09-04 2022-03-10 Synthon B.V. Improved process for preparation of apalutamide
CN112679468A (en) * 2021-01-05 2021-04-20 四川科伦药物研究院有限公司 Crystal form of apatamide, preparation method and application
WO2023143090A1 (en) * 2022-01-25 2023-08-03 成都苑东生物制药股份有限公司 Novel crystalline form of apalutamide solvate and preparation method therefor
CN115536634B (en) * 2022-10-17 2024-06-11 上海博悦生物科技有限公司 Synthesis method of apatamide
CN116332907A (en) * 2023-03-16 2023-06-27 奥锐特药业股份有限公司 A kind of preparation method of amorphous apalutamide
WO2025153768A1 (en) * 2024-01-18 2025-07-24 Nanoform Finland Oyj Composition comprising crystalline nanosized apalutamide

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US5323907A (en) 1992-06-23 1994-06-28 Multi-Comp, Inc. Child resistant package assembly for dispensing pharmaceutical medications
US7709517B2 (en) 2005-05-13 2010-05-04 The Regents Of The University Of California Diarylhydantoin compounds
CN101032483B (en) * 2006-03-09 2011-05-04 陈德桂 Hydantoin derivative for adjusting estrogen receptor activity and application thereof
PL3412290T3 (en) 2006-03-27 2021-09-06 The Regents Of The University Of California Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases
CA2648139A1 (en) * 2006-03-29 2007-11-08 The Regents Of The University Of California Diaryl thiohydantoin compounds and their use in the treatment of hyperproliferative disorders
WO2008119015A2 (en) * 2007-03-27 2008-10-02 Sloan-Kettering Institute For Cancer Research Synthesis of thiohydantoins
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ES2809738T3 (en) 2012-06-07 2021-03-05 Aragon Pharmaceuticals Inc Crystalline forms of an androgen receptor modulator
WO2019242439A1 (en) 2018-06-20 2019-12-26 苏州科睿思制药有限公司 Crystal form of arn-509, preparation method therefor and use thereof

Also Published As

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HUE054595T2 (en) 2021-09-28
MY187500A (en) 2021-09-24
TW201402561A (en) 2014-01-16
SI3348553T1 (en) 2020-11-30
CA2875767A1 (en) 2013-12-12
RS61988B1 (en) 2021-07-30
EA201492272A1 (en) 2015-05-29
US20190241539A1 (en) 2019-08-08
IL267608A (en) 2019-08-29
PE20200795A1 (en) 2020-08-10
HUE038082T2 (en) 2018-09-28
US12018008B2 (en) 2024-06-25
RS60617B1 (en) 2020-09-30
MX356754B (en) 2018-06-11
EP3533792A1 (en) 2019-09-04
PE20200725A1 (en) 2020-07-21
KR102195916B1 (en) 2020-12-30
MX2014015005A (en) 2015-09-04
KR20150021993A (en) 2015-03-03
PL3348553T3 (en) 2021-02-08
TWI532732B (en) 2016-05-11
LUC00236I2 (en) 2025-02-03
LT3533792T (en) 2021-07-26
LT2858985T (en) 2018-09-25
AU2013271751B2 (en) 2017-02-23
CN104619692A (en) 2015-05-13
EP3348553B1 (en) 2020-07-08
SI2858985T1 (en) 2018-12-31
ZA201500076B (en) 2016-10-26
CY1120393T1 (en) 2019-07-10
CR20140549A (en) 2015-04-06
FR21C1050I1 (en) 2021-12-10
IL259738A (en) 2018-07-31
HRP20201387T1 (en) 2020-11-27
CA3055660A1 (en) 2013-12-12
HK1210175A1 (en) 2016-04-15
US20210163441A1 (en) 2021-06-03
PL3533792T3 (en) 2021-11-29
FR21C1050I2 (en) 2024-05-24
US20190330182A1 (en) 2019-10-31
EP3922629A1 (en) 2021-12-15
EA033956B1 (en) 2019-12-13
ES2670683T3 (en) 2018-05-31
HUE050357T2 (en) 2020-11-30
PT2858985T (en) 2018-07-10
US20170001977A1 (en) 2017-01-05
US20250092011A1 (en) 2025-03-20
ES2809738T3 (en) 2021-03-05
HK1226066A1 (en) 2017-09-22
JP2018141009A (en) 2018-09-13
CA3008345A1 (en) 2013-12-12
IL320522A (en) 2025-06-01
EA201992010A1 (en) 2020-01-24
IN2014DN10084A (en) 2015-08-21
NZ702203A (en) 2016-09-30
UA123142C2 (en) 2021-02-24
DK2858985T3 (en) 2018-05-28
CR20190331A (en) 2019-11-12
IL259738B (en) 2021-06-30
SG11201408140QA (en) 2015-01-29
AU2017200298B2 (en) 2017-09-28
GT201400283A (en) 2017-07-03
SI3533792T1 (en) 2021-11-30
PT3348553T (en) 2020-09-28
WO2013184681A1 (en) 2013-12-12
LTPA2021525I1 (en) 2021-11-25
CY2021032I1 (en) 2022-03-24
US10526310B2 (en) 2020-01-07
EP2858985B1 (en) 2018-04-18
NI201400142A (en) 2016-12-02
US10934271B2 (en) 2021-03-02
CN113135892A (en) 2021-07-20
EA028791B1 (en) 2017-12-29
JP2015518890A (en) 2015-07-06
US20200354335A1 (en) 2020-11-12
HRP20180902T1 (en) 2018-08-24
US20180258067A1 (en) 2018-09-13
CA2875767C (en) 2018-08-14
AU2017279807B2 (en) 2018-11-08
AU2017279807A1 (en) 2018-01-25
KR20190132543A (en) 2019-11-27
ECSP14030098A (en) 2016-01-29
NZ717683A (en) 2018-04-27
AU2013271751A1 (en) 2014-12-18
ME03081B (en) 2019-01-20
CL2014003331A1 (en) 2016-03-04
JP6182209B2 (en) 2017-08-16
IL236055A0 (en) 2015-02-01
PH12014502714A1 (en) 2015-02-02
JP6345821B2 (en) 2018-06-20
CA3114726A1 (en) 2013-12-12
PH12014502714B1 (en) 2015-02-02
HRP20210909T1 (en) 2021-09-03
US10556882B2 (en) 2020-02-11
SG10201610249TA (en) 2017-02-27
IL275413A (en) 2020-07-30
EA201791592A1 (en) 2018-01-31
ES2875932T3 (en) 2021-11-11
BR112014030678A2 (en) 2017-06-27
CA3008345C (en) 2019-10-22
IL267608B1 (en) 2025-06-01
CN105693692A (en) 2016-06-22
EP3348553A1 (en) 2018-07-18
DK3348553T3 (en) 2020-07-27
US10766875B2 (en) 2020-09-08
PH12016501470A1 (en) 2017-07-10
ME03815B (en) 2021-04-20
US9994545B2 (en) 2018-06-12
PE20150631A1 (en) 2015-05-11
AU2017200298A1 (en) 2017-02-02
PL2858985T3 (en) 2018-09-28
LTC3533792I2 (en) 2024-07-10
US10308630B2 (en) 2019-06-04
IL267608B2 (en) 2025-10-01
KR102062024B1 (en) 2020-01-03
SMT202000496T1 (en) 2020-11-10
TR201808939T4 (en) 2018-07-23
NL301144I2 (en) 2025-03-20
CO7240407A2 (en) 2015-04-17
DK3533792T3 (en) 2021-06-28
JP2017178923A (en) 2017-10-05
LT3348553T (en) 2020-09-25
CY1123427T1 (en) 2021-12-31
PT3533792T (en) 2021-06-07
NO2021046I1 (en) 2021-11-02
SMT201800311T1 (en) 2018-07-17
US9481663B2 (en) 2016-11-01
RS57370B1 (en) 2018-08-31
CY1124831T1 (en) 2022-03-24
UA115665C2 (en) 2017-12-11
EP3533792B1 (en) 2021-05-05
SG10201610248SA (en) 2017-02-27
US20150133481A1 (en) 2015-05-14
EP2858985A4 (en) 2016-05-25
SMT202100355T1 (en) 2021-07-12
EP2858985A1 (en) 2015-04-15
HUS2100047I1 (en) 2021-11-29
US20200115361A1 (en) 2020-04-16
CY2021032I2 (en) 2022-03-24

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